Note: Descriptions are shown in the official language in which they were submitted.
V6~0 93/12002 PCI'/1JS92J1091~
2~.2~5J1
SYSTE1~I FOR ACCOMMODATING wITHDRAWAL
~F LIOUID FROM A BUL% SUPPLY
TECk~TICAL FIELD
The present invention relates to a fluid
transfer system for accommodating the withdrawal of
liquid from a bul~C supply for use in medical procedures.
The present invention is particularly well-suited for
use with bulk reconstituted, toxic drugs, such. as
7.0 chemotherapeutic drugs.
BACRGROTJi~ID OF TIDE INVE~TTIflN
AND
TEC~iNICAL PROBLEMfS POSED BY THE PRIOR ART
Various medical procedures require the
transfer of fluid from 'one fluid-containment system or
fluid-conducting system to another flu~.d~-containment
system or fluid-conducting syst~~n. Typically, one of
the two s~rs~ems includes a c~ntainex for a bulk supply
o~ liquid, s~zch as a ~ulx supply of a reconstituted,
~~? liqu~.d, chemothexap~u~ic drug. The other system, which
i cap be as simple as a syringe; may b~'connected to the
f irSt System ~~r ~nly a Short per7.od Of t3.me, Or
interam~tter~tly, to 'facilitate the' withdrawal of a
desired am~unt-~r dose of thr liqu~:d for ~dministratiora
~~ ~~transm~~~lon t~a patient.
. Tn those medical applications where the (first
system includes a container fa~~ ~ bu~.k supply of a toxic
~~~~d~ 1.t 3,5 C~euiralal~, if not neCeSSary, to prei~L'nt
i inad'~t'erte'nt eXp~Sllre of p~rSOnIlel t0 t$~e, t~X7.0 liquid.
For example; a hospital pharmacy may prepare highly
toxic, chemotherapeutie drugs far use in treating cancer
. patients. Typically, a ~tial of a highly concentrated,
~.~axic drug is rec~i~re~ from the pharmaceutical supplier
b~ the hospital pharmacy;: and the hospital personnel
35 then admix the concentrated drug with a suitable diluent
W~ 93/1.2002 PC'I'/~JS92/1091f~
_ 2 _
to provide a bulk reconstituted supply having a reduced
concentration or effective dose per unit volume that
permits the administration of a prescribed amount or '
volume directly to the patient. ,
The preparation of the bulk reconstituted,
liquid drug is typically carried out in a protective
environment, such as in a laminar 'flow hood which is
specially designed to maintain a negative pressure
within the hood so as to prevent the escape of toxic
vapors. ,"
The bulk reconstituted, liquid drug is usually
stored in a suitable container which may be a flexible,
thermoplastic, sealed bag., A suitable. discharge
structure, dispensing structure, or fitment is typically
provided on the bulk container to accommodate withdrawal
of a desired amount of the liquid from the container.
It is, of course, desirable to ensure that the means for
withdrawing a prescribed amount of the toxic liquid drug
will not result in spills or leaks from the bulk
! ~0 coast finer.
Accordins~ly, it would be advantage~us to
provide a barrier system which could be employed with a
container of a bulk supply of a toxic drug and which
would functi~n to contain a leak or leaks of the liquid
drug from the container, or from as~c~ciated ccannections
thereto, so as to prevent exposure ~f personnel to the
d~ .
It ~rould also be desirable to provide such a
barrier system ~rith means'for accommodating its
3~ disposition in association with, or its connection to,
the bulk supply container in a manner that can be
d
relat~.vely easily and qusckly effecteda
It w~uld also be beneficial if such a barrier
system could be provided with a structure that would
accommodate movement or transport of the bua.k supply
'Wf~ 93/120(i2 PCH'l1JS92A1~9~~
_ . ~ 3 ~122~~~.
from one location to another while still maintaining the
efficacy of the barrier system against leakage.
Further, it would be desirable to provide such
a barrier system with means for accommodating withdrawal
of the bulk reconstituted, liquid drug by means of a
suitable, conventional syringe, especially a syringe
having ~ luer fitment.
It would also be advantageous for such a
barrier system to function to prevent inadvertent
l0 .injection of the liquid drug, or other material, back
into the bulk container so as to reduce the probability
of contamination of the bulk supply.
In addition, it would be beneficial if the
barrier system could accommodate the use of,_~ syringe to
withdraw the liquid drug from the bulk supply and to
pump a desired volume of the liquid drug into a selected
a conduit for ~d~inistrat~.on to a patient or for delivery
to another container or containment system.
_ den a bulk-container of liquid is employed
for supply~.ng small quantities or doses of the liquid
-, drug via withdrawal by a syringe, it would be desirable
~o pr~vide means for accommodating the asp~.ration or
dasdharge from the syringe ~f an excess amount of the
liquid, er of a' portion of the la.quid in rahich an air
2~ bubble is entrained, that may have been drawn into the
syr .l.nge a Tt would b~ desirable t~ prov~.de Such a
cap~bi.lity regardless o~ whethex or not the bulk supply
~f liquid is toxica
accordingly, it'would be des~.rable to provide,
a suitable receiving compartment or receptacle for
excess liquid ~ndJor for a mixture of liqu~.d and air., in
conjunction raith a syringe~operated transfer or
~rithdrawal system operable ~n a bulk supply. It would
be beneficial if such a receptacle could be provided as
a unitary or integral part of the withdrawal system and
WCs 33/1202 PL~'/iJS9z/1o918
could also be adapted for use with a barrier system that
prevents exposure of personnel to leakage.
Further, in view of the dangers associated
with toxic drugs, contamination, and infection, it. would
be desirable to provide a barrier system and/or
receptacle system which would facilitate its use as a
.disposable item. To this end, such a system or systems
should be relatively inexpensive. Accordingly, such
systems should incorporate an improved component design
that accommodates relatively simple manufactur~.ng
~~
processes and assembly processes to keep the total cost
as low as ponds.6.ble s
The systems should also function to
effectively seal at connection points or attachment
points to prevent leakage of fluids and to prevent
ingress of airborne or liquid-carried contaminants.
Addaait~nally, the systems 'should preferably
function effectively with a var~.ety of f~.uids throughout
a range ~f fluid pressures.
Advantage~usly, the systems should have a
suitably long shelf life and active use life. Further,
such systems should pre~exably be adaptable to function
effectively after repeated connectior~~ to a syringe.
Sg3I~lARY ~F THE INVENTION
t ~~ The present invention provides a novel fluid
trane~er .cyate~a for accoynm~clatia~g th.e wa.thdrawal of
liquid form, a hulk supply., Ln the preferred form, the
iawent~:on permits a bulk supply of hazardous liquid to
r
,be prepared, such as by thh admixing of a highly
3~ concentrated, t~xic drugwith a diluent, while
preventing or minimizing exposure ~f personnel to the
ha~aard~uw~J.l~.qu~.d w Thl.J ~~J facl~~.tatedby the use of a
I10'ttt:l barrier syS'Gem w$ll.ch iS imperVl.ous t0 the ll~uid .
~'he harrier system of the pgesent invention
35 functions effectively to protect personnel from spills
i~V~ 93112002 PCT/tJS92/109~~
or leaks of a hazardous liquid during withdrawal of the
liquid from a bulk supply and/or during preparation of
the bulk supply. The barrier system conveniently
permits manual operations to be performed on various
components, such as a small container of a highly
concentrated, toxic drug and a larger container of a
diluent liquid.
The barrier system accommodates the movement
'or transport of a bulk supply of liquid from one
location to another while maintaining the efficacy of
the barrier system protection against leakage. Further,
the barrier system accommodates the convenient
withdrawal of liquid from the bulk supply by means of
conventional components, such as a suitable syringe,
r,
Another aspect of the invention, which can
provide operational advantages with or without a
,;
protective barxier system ~f the type referred to above,
relates to a system for accommodating the collection of
unwanted or excess lis~u~.d that has been inadvertently
withdrawn or otherwise withdrawn from a bulk supply. In
particular, when a syr~.ng~ is used for withdrawing
liquid from a bulk supply container, the system permits
a p~r~;ion of he liquid in tae syringe, which nay be an
y excess amount, or which may contain an air bubble, to be
discharged frown tla~ syringe to a hovel waste receptacle.
The liquid transfer and waste--receiving system
is adapted to be ~e~nveni~ntly used in conjuhction with a
bulk supply ~f liquid: The waste-receiving system is
especially well-suited for use in conjunction with, and
as a ~.n~tegral part of, the above--discussed 'personnel
p~rQtection barrier system.
Both systems, whether provided separately or
' ~s ~n integra2 combination sys~e~n, can incorporate
improved comp~nent designs which accommadate relatively
simple manufacturing processes and assembly processes so
TWO X3/12002 PCTI~.J~~2/90g1~
21~~a~1.- 6 -
as to keep the total cost as low as possible. The
systems can function effectively with a variety of
fluids through a range of fluid pressures. The systems
accommodate designs that provide a suitably long shelf
life and active use life.
In one preferred forna of the invention, a
protection system is provided for a container from which
a hazardous liquid can be removed. The system includes
conduit means for being connected to, and extending
~.0 .from, the container to define a flow path for the liquid
from the container to a discharge location exterior of ~..
the container. A flexible~barrier, which is impervious
to the liquid, is penetrated by, and sealed to, the
conduit means. The flexible barrier accommodates at
2.5 least two arrangementsa (1) an initial arrangement in a
;.,
',s retracted orientation permitting access to, and
manipulation ~f, at 3east a portion~of the conduit means
and cantainer: and (~) a subseguent arrangement in an
extended orientation.envelop3ng a port~.on of the conduit
2c3 teens and the connected container.
The lic~id transfer car withdrawal system,
which may operate separately from, and independently of,
the above-descr~.bed barrier system, accommodates the
withdrawal of liquid from a container with a syringe.
25 The withdrawal system'includes ~ first conduit means for
~eia~g connected at ores end to, and for extending from,
the csantainerv The'first conduit weans is connected at
another end to the syringe to define a flow path for the
liquid between the contaixrer and the syringe.
~~ A second c~nduit means is provided for
de fining a flow patYa f~r the ~.ic~uid from a first end
eonnected to, and in fluid communication writh, the first
conduit means:- The receptacle is connected to the
second end of the second conduit mc~ns and is in fluid
' 3~ commuhi,cation therewith. ~4 first one way, non-return
~V~D 93/2002 P~'T/US92/1091A
- ' - ~.~~2~~~
valve is provided in the first conduit means in the flow
path between the container and the second conduit means
to prevent flow into the container. A second one-way,
non-return valve is provided in the second conduit means
to prevent flow out of the receptacle to the first
C'rondu,l.t means o
Numerous other advantages and features of the
present invention will become readily apparent from the
following detaa.led description of the invention, from
.the claims, and from the accompanying drawings.
BRIEF DESCRIP'X°ION OF THE DRAWINGS
In the accompanying drawings that form part of
the specification, and in which like numerals are
employed to designate like parts throughout the same,
FIG. 1 is a partially exploded, perspective
view of the components of a preferred form of the
present invention shown in a first ox~.entation in
conjunction with a drug vial and diluent bag, and a
potion of a coanponent of, the -invention has been broken
~~ away to better illustrate interior details
FIG. 2 is a view similar to FIG. 1, but FIG. 2
shows the components after various fluid connections
have been made end after the components have been
rearranged in a°se~ond orientation to provide protection
against fhaid leak~ge~
FIG.,3-is an enlarged, fragmentary, side-
elevational view taken generally along the plane 3-3 in
FI~e~C
FIG. 4 is an enlarged, fragmentary, side
30 elevational vie~ri taken generally along the plane 4-4 iri
F~~e~%
FIG. ~ is an enlarged, fragmentary,
elevational view taken genera~.ly along the plane 5-S in
FIG. zs
vv~ 9~rizoo2 Pcrru~gzr'o9~s
$_
_
FIG. 6 is a simplified, diagrammatic, front
elevation view of a second embodiment of the invention
wherein the components are shown in a first arrangement
prior to use: and
FIG. 7 is a simplified, diagrammatic view
'similar to FIG. 6, but showing a side elevation after
the com~aonents have been connected~to a bag containing a
bulk reconstituted supply of an admixed drug from an
yattached vial and wherein the system components are in a
v 7.0 second arrangement providing an enveloping barrier
against leakage.
DESCRIPTION OF ~'HE PREFERRED EMBODIMENTS
the present invention provides a novel
transfer system,f~r accommodating the withdrawal of
~:5 Liquid from a bulk supply. ~'he invention is
particularly er~ll~-suited for use witlh bulk
reconstituted, toxic drugs, such as~chemotherapeutic
drugs.
Onc asp~ctvof the invention relates ~Co a novel
barrier systeyn for px~tecting personnel from leaks or
spills of a hazardous liquid that is stored in a
container from which the liquid can be removed. Another
aspect of the inventian, which may be included as an
integral part 'of, br ~rhich may be er~tireZy independent
;, ~5 ofo the b~rxi~r system, provides ~ unique lic,~uid
transfer syste~a for accom~aodating 'the use ~f a syringe
t~ draw liquid from a container. The liquid transfer
syste~'prcvides a novel receptacle for receiving a
Potion of the~withdrawn liquid which may be an excess
3C amount and/or which'may contain an entrained air bubbl'e~
Whxile this invention is susceptible of
embodiment in many different forms, this specification
end the accompanying drawings disclose only some
specific forms as examples of the invention. The
35 x.n~ention is not intended to be lianited to the
!N~ 93/12002 P~.'I'/US92/109~18
'~ ~ ~ - ~~.~2~~.~
embodiments so described, however. The scope of the
i invention is pointed out in the appended claims.
For ease of description, the system components
of this invention are described in an arbitrarily .
selected operating position, and ternns such as upper,
lower, horizontal, etc., are used with reference to this
position. It will be understood, However, that the
components of this invention may be manufactured,
stored, transported, and sold in a partially or fully
1~ disassembled state, as well as in orientations other
than that described.
The figures illustrating embodiments of the
components show structural details that will be
recognized by one skilled in the art. However, the
~5 detailed descriptions of all such details are not
necessary to an understanding of the invention, and
accordingly, are not'herein presented.
The system components of th~,s invention may
typically be used with certain c~nventional components
2~ the details of which, although not fully illustrated or
described, will be apparent to those having skill in the
art ~hd an understanding of the necessary functions of
such components.
The fist embodiment of the presea~t invention
2~ is illustrated ixa FIGS. 1-5 wherein'a tgansfer system is
designated generally by the reference numeral ~Ø The
' system 1~ malr be eonv~niently employed to accommodate
3 the preparation and use of a bulk reconstituted, toxic
drug. A t~xic drug is typ~.cally provi~ted in a highly
3~ concentrated form contained in a small via1~12. The
v~el 12 typically includes a removable closure 1~ which
is initially sealingly mounted over the mouth of 'the
container 12 and sealed thereto with a frangible web.
The closure 14 can be torn away to permit removal of the
VSO 9311002 P~'1US92/1091~
--
closure 14 so as to expose exterior threads 15 on the
neck of the vial 12.
The opening or neck of the vial 12 typically
contains an internal, removable, resilient, seal plug 23
5 (not visible in FrG. 1 but shown removed in FIG. ~) the
seal plug 23 defines an outwardly opening receiving
cavity or recess, and the seal plug 23 prevents the
discharge, or removal, of the licxuid contents from the
vial 12 unless and until the plug 23 is engaged and
10 removed in a certain manner by an appropriate mating
structure, such as may be incorporated in a bulk supply'
container or bag 20 described hereinafter.
A conventional vial 12 is sold in the U.S.A.
as part of the Add-Vantage~ brand bulk reconstituted,
drug system sold in the U.S.A. by Abbott ?aaboratories,
Inc., One Abbott Park Road, Abbott Park, Illinois 60064-
~~00 UeSoA. ~he detG~~.led de~uZgn and w~9pec,.f~..c Structure
of the vial 12 f~xm no part of the present invention.
The bulk supply container or bag 20 may be of
any appropriate desagn that is suitable for use with the
particular liquid ~,o be stored and that is suitable for
use with the vial 12 if such a vial 12 is employed.
The bag 20 is preferably fabricated from a
convent,aonal, , flexible, transparent, thex~noplasta.c
2a materials The bag 20 a~~rmal~y ~rould be furnished to a
hospital or other user with a bulk supply of liquid
healed therelne I~ thebag. 2~ ZS t~ b~.used for the
administrate~n of a toxic drug, the bag 20 may domain a
di3uent liguid and may be,adapted to be connected to the
highly concentrated !drug vial 12. ~ '
To this end, the bag 20.includes a neck 26
defining an- operair~g to the bag interior. The opening is
initially occluded with an outer closure 30 that is
connected to the neck 26 with a frangible seal. The
~5 outer closure 30 can be torn away from the bag neck 26
'W~ 93/12002 PC~'fUS92/lfD9l~
11 _
~1~~7~1
to perm~.t the vial 12 to be coupled to the neck 26. Ta
this end, the neck 26 may include internal threads 27
for mating with the threads 15 on the neck of the vial
12.
Inside the bag neck 26 there is an inneb plug
3~ with an upwardly projecting member knot visible) for
being received in the recess of the seal plug 23 inside
the neck of the vial 12 and for tightly engaging the
resilient seal plug 23. As the vial 12 and bag 20 are
,screwed together, the projecting member is driven into
Engagement with the vial seal plug 23. Next, the bag
plug 34 is manually disengaged from the bottom of the
neck 26 by pushing the flexible walls of the bag 20
against the projecting flange of the plug 3A. and pulling
tae plug 34 out of the neck 26. this causes the
projecting member of the plug 34 to also pull the
engaged seal plug 23 out of the neck of the vial 12.
the two~ engaged plugs then drop together to the bottom
of the bag 20 as illustrated in ~'ZG. 2. .
The above-described structure of the bag neck
and end closure is a conventional design provided on
fags for use ~tith the above-described type o~ vial ~1.2.
Such ~ bag neck and cl~sure structure is employed with
bags furnished with the above-described Add~~Tantage~
25 dgug ~dminis~rat~.~n system sold ~y Abbott Laboratories,
anc. the detai~:ed design end specific structure of the
deck 2C,:outer closure 30, and inner plug 34 form no
part ~f~~he present invention. Designs for the
cohnection st~acture for the bag 20 and vial 12 are also
'disci~sed in the Abb~tt Laboratories; Inc.,. UsS. Patent
~los: 4,~1A,2f7, 4,614p5~.5, and 4,757,911.
After he plugs have been dislodged frown the
necks of the bag 20 end vial 12, the concentrated liquid
dig from the vial 12 flows into the bag 20. ~'he
flexible bag 20 may then be kneaded or otherwise
'!~~ 93/1202 PC.'1'/1J592J109~~
- 12 -
manipulated to effect a thorough mixing so as to produce
a bulk. reconstituted drug having a much lower
concentration. The lower concentration is determined,
of course, by the initial amount of the concentrated
drug in the vial 32 and by the initial amount of the
diluent in the bag 2~.
At the end of the bag 20~opposite the neck 26
there is a discharge structure or dispensing fitment 40
(FIG. 1). The fitment 4~ includes a suitable tube 42,
.such as a rigid, thermoplastic tube which projects from
the bottom of the bag 2~. The tube 42 extends through ~~
the flexible end wall of the bag 20, and the bag wall is
sealed araund the periphery of the tube 42. This seal
may be effected with conventional heat seal techniques,
with adhesive, or by other means, the details of which
form no part of the present invention.
The ttabe 42 is in fluid communication with the
liquid in the interior of the bag 20. The liquid is
prevented from discharging from the tube 42 by a
2~ suitable closure or fitmer~t 46 which is preferably in
the form of a seal or "reseal" that accommodates
penetration by a suitable hollow spike, boll~w needle,
or cannula. Such a reseal 46 typically functions to
perm~.t the insertion of a hollow needle or spike to
e~tabl~.sh communicatibn with the liquid in the tube 42
while the reseal seals tightly around the periphery of
the beadle. The x~eedlc can be later withdrawn, and the
reseal. 46, owing to the inherent resiliehcy of the
reseal material, closes at the penetration site from
~0 which the needle has'been removed so as to prevent
egress of the lie~uid.
then a toxic drug is provided in a vial 1.2 for
being admixed with a diluent liquid in a bag 2c3 as
described above, the vial 12 and bag 20 are typically
~5 manipulated in a controlled environment, such as in a
'WCa 93/12002 pC1'/US92/1091~
- 13
2122a~~.
laminar flow hood (not illustrated). The hood is
maintained under negative pressure to prevent the escape
of toxic vapors if there should be any inadvertent leak
and to othexw~tise provide protection to the person
handling the components. although conventional vials
arid bags are typically manufactured under strict quality
control standards and function well 'to prevent
inadvertent leakage when properly handled, there is a
desire, because of the highly toxic nature of many of
the drugs, to provide an improved system for eliminating
or reducing the likelihood that personnel will be ..
exposed to the drugs during the reconstitution process
and thereafter when tie reconstituted drug is stored and
used..
To this end, one aspect of the present
invention provides a novel protection system for use
with a container of hazardous liquid, including the
above-described pouch 20 and connected vial 12. In the
preferred form ~f the protect~.on system illustrated in
FIG. l, a first aonne~ting means 50 is provided for
being connected t~ the container 20 to establish fluid
communication between the exterior~of the container 20
and the liquid inside the container. In the preferred
form illustrat~d,:the connecting means,50 includes a
hollow, sharp sgike 52 which is mflunted to~one end of a
hollow,- cylindrical fitment 54 (FIGSa 1 and 4). The
other end of the fitm~nt 54 is sealed to a hollow,
flexible tube or other suitable conduit 56 in a manner
that estab33shes fluid cor4munication between the
ihterior of the hollow spike 52 and the conduit 5'6. The
attachment of the hollow spike 52 to the conduit 56 via
the fitmer~t 5~ may employ conventional; interior,
sealing end amounting configurations (not visible in the
figures) well known to those of ordinary skill in the
art. The detailed design and specific structure ~f such
W~ 93/12002 ~'CTltJS92110918
,.,.,,
a connection, and the detailed design and specific
structure of the hollow spike 52, form no part of the
present invention.
D
A latch or clip 60 (FIGS. ~l~and ~) is provided
to hold the spike 52 to the container 20. The clip 60 ,
has a pair of feet 62 at one end which are mounted to
the conduit 56 adjacent the fitment 54. A spring arm 66
extends from the feet 62 and terminates in a tab 68. A
pair of latch bars ?0 extend outwardly from the spring
arm 66 for frictionaliy engaging one side of a flange ?~
on the conduit 42.
Initially, the clip 60 is held outwardly (as
shown in FIG. 1~ while the hallow spike 52 is forced
into the reseal 46. Then the clip 60 is then pushed
toward the tube 42 so that the arms ?0 engage the flange
?4 and prevent inadvertent withdrawal of the hollow
spike 52.
Typ,icall~, the vial 12 and bag 20 would be
screwed together before ~he hollow spike 52 is inserted
y 2~ through the rsseal'~6.. ~iowever, the hollow spike 52
could be inserted-thr~ugh the res~~1 46 firsts and the
vial 12 end bag 20 could be subsequently connected
t~gether.
- ~ unique; flexible barrier 80 (FT~~s. 1 and 2)
is pr~vided as an integral part of the system along with
the c~nduit 56 and connecting-means 5d~: The flexible
barrier 8o is penetrated 3~y the conduit 56 and is sealed
- a~~ut the peripher~T of the conduit 56 at he
penetration.
' Tha barrier 80 is preferably fabricated'from;a
suitable materaal whack is sufficiently transparent to
permit some degree of,visual inspection through the
barrier. The barrier 80 pbeferalaly is fabricated from a~
synthetic, thermoplastic; polymer material, and
preferably has the shape of an openended enclosure,
~c~ g~ia~on2 a'creus92ia~~a~
~12~~~~
bag, pouch, envelope, or the like. A preferred material
for the barrier 80 is linear low density polyethylene or
flexible polyvinyl chloride.
The barrier 80 is sufficiently flexible to
a accommodate an initial arrangement in a retreated-
orientation (FIG. 1~ which permits access to, and
manipulation of, at least a portion of the connecting
means 50 and a container, such as the container 20. The
barrier 80 is also sufficiently flexible to accommodate
a subsequent arrangement in an extended orientation
(FIG. 2) for defining an enclosure around the connecting
means 50 and connected container 20.
The open end of the barrier 80 is preferably
provided with a sealing means for completely closing or
sealing the open end of the barrier 80. To this Brad,
one such sealirlc~ means i~ illustrated in FIGS. 1-3 and
includes a pliable, but non-resilient, member carried in
the wall of the barrier 80 and having end portions 92
projecting from the wall of the barra.er 80. After the
barrier 80 has beea~ arranged to enclose the vial 12 and
bag 20 as illustrated in FIG: 2, the open end of the
barriex 80 can be closed and 'then folded over a few
times (ass illustrated in FTGS. 2 and 3). The extending
ends g2 of the pliable member can then be bent around
each s~.de of the u~f~lded portion o~ the barrier to hold
the f~3.d~ tightly against the unfolded portion of the
barrier. Thi~'effects a generally leak-fight seal.
~ther forms of closures or'seals for the open end of the
barrier 8~ may be employed, and such other forms may be
of a ~u~.table special or conventional design.
The canduit 5C may be characterized as
generally extending from the first connecting means 50,
~wthrough the barrier 80, and to a discharge 1~cation
exterior of, and spaced-away from, the bag 20. The
condu~.t 56 inclhdes a one-way, non-return valve or check
'VNO 93!12002 PC I'JUS92110918
valve 102» The check valve 1,02 prevents flow into the
container or bag 20.
The check valve 102 may be of a suitable
special or conventional design. A suitable conventional
v 5 valve is that sold in the U.S.A. under the designation
Normally Closed Check halve by Burton Medical having an
office at Uethlehem, Pennsylvania.,
In the preferred embodiment illustrated in
FIGS. 1 and 2, a special or conventional Y-fitment or
fitting 108 is provided in the first conduit 56 for
reasons described in detail hereinafter» The Y-fitting..
108 is connected to the conduit 56 between an inlet leg
of the ~~Y~~ and the common outlet leg of the ~~Y~° .
The Y-fitting 108 may be of a suitable special
1,5 or conventional design. One suitable conventional Y-
fitting is made under the designation ~.ist No.~75-0128
Y-fitment by I~rbbott T.~boratories having an office at
:,North Chicag~, Illinois.
A second c .~nnecting means lls is connected to
the distal end Of the. first conduit 56, and the second
connecting means lls is adapted to be connected to a
sy~°inge 120 t~ establish fluid comnnunication between the
bag 20 and the syringe 120. The seceand connecting means
x,16 may be a sp~Gial or C~nventional device, and one
5 such suitalale device as ~ valve sold in the U . ~ s 1~ s under
the designati~n "~3urron Reflux~' by ~urron Medical s~hich
has an office at Ue~hlehem, Pennsylvania. Such ~ valve
his an a.nternal~v~lve ~~~er (not visible that is
normal~.~ biased to occlude a discharge port, and the
'discharge p~rt includes a'generally cylindrical
receiving wall around the port for accommodating the
a insertion of the distil end of the syr~~age 120.
In a preferred form illustrated in FIG. 1, the
seeond connecting means 116, in the form of the above- a
:'a 35 d~s~cribed valve, defines a conventional, female, lust
wC~ 93WOOZ PC11'f~JS92/1o918
- 17 -
- ~~.2~~~1
fitment for receiving a mating, male, leer fitment on
the distal end of the syringe 120. When the male leer
fitment of the syringe 120 is inserted into the female
luer fitment of the valve, the valve member within the
valve is pushed away from its seat by an internal°cage
engaged with the distal. end of the syringe luer fitment.
This opens the valve port and perm~.ts the liquid to be
discharged through, or drawn through, the valve by
operation of the syringe 120 in the usual manner to
effect a suction within the syringe 120.
When the desired amount of liquid has been ...
drawn into the syringe 120, the syringe is pulled out of
the valve (i.e., connecting means 116, and the internal
valve member is biased to again occlude, and seal, the
valve port.
A suitalble safety cap 126 may be provided for
being mounted on the distal end of the valve or
eonraecting means 116. To this end, the cap 126 may be
of the convents.~nal ty_ pe nArmally px°ovided with, such a
2~ valve wherein the cap 126 includes a suitable a.nternal
thread structure for engaging a mating thread form or
partial tlhread form on the exterior of the distal end of
the valve.
Irt the preferred form of the invention
illustrated in FI~s-: 1 end 2, a second conduit or tube
132 is connected ~t a fi.r~t end to the sec~nd lec~ of the
Y fitting 108 in fluid communication with the first
G°O'ndu~.t 56.0 The seC'rond condul.t 1°32 e'xtend',~~'' baCr~C
through
the barrier 80 t~ a'recep~acle 140. In the preferred
form illustrated 'in~ FIGSs' 1' and 2,' the receptacle 140
has the form of ~ flexible pouch or bag defined by two
sheets of flexible material with generally coterminous
edges which arm dialed together about their peripheries.
The interior of the redeptacle or pouch 144 is in fluid
VVVO 93/12002 P~'I'/~LJS9211~9'8
21~~~~~.
-18-
comxaunication with the interior of the second conduit
132.
At the location where the second conduit 132
penetrates the barrier 80, the barrier 80 is sealed
around the periphery of the second conduit 132 by~
suitable special.or conventional means such as described
above with respect to the barrier penetration seal for
the first conduit 56.
The second conduit 132 includes a second, one-
way, non-return valve 150 for preventing flow of, liquid
from the receptacle.or pouch 140 into the first conduit,
56. The one-way, non-return valve 150 may be a special
or conventional check valve identical to the valve 1.02
employed in the first conduit 56 as described above.
1.5 However, the second check valve 150 is, of course,
oriented in the direction opposite to that of the
orientation of the first check valve 102 so that the
second check valve 150 prevents flow toward the Y-
fitting ~arh~reas the first check valve 102 prevents flow
away from the Y~f~.tt~ng lVBo
The preferred form of the invention
illustrated in DIGS. l and 2 also includes a three-way
valve 180 which,, as illustrated i~ FIGS. 1 and 2, is
located in the second conduit 132 between the receptacle
1~0 and the second check valve 150. As illustrated in
FTG. 5, the three,°way valve 180 includes a body 182 with
three outwardly projecting conduit members 191, 192, and
193 which each define a port.pommunicating with the
ynterior of the valve body 182.
The v~lve'180 als~ includes a rotatable valve
member 7.96 defining an internal, T-shaped flow passage
1~8~ Flotation of the valve member 196 permits the
'' internal flow passage 198 in ache valve member 196 to be
aligned between the port conduits 191 and 193 while
occluding the post conduit 192 as illustrated in I~IG. 5.
WO 93/12002 3~CT/L1592/A0918
The valve member 196 can also be rotated to another
position to establish fluid communication between the
port conduits x.92 and 193 while occluding the port
conduit x.91. Of course, the two other po.;itions of the
valve member 196 are possible, but such other posi't'ions
would n,ot typically be employed during the use of the
invention, and such other positions are not described in
detail herein.
~t least the port conduit 192 may be provided
1.0 with an exterior thread form 202 for receiving a.safety
cap 20~. The safety cap 20~ includes an internal thread
forms 206 for matingly engaging the thread forty 2~2 on
the port conduit 7.92 and also includes an internal,
hollow, cylindrical plug member 208 for being received
1.5 within, and occluding, the port 192.
The valve 180 may be a conventional valve such
as the valve sold under the designation 4 Way ~topcoek
by edex, Inc. having~an office at Hilliard, Ohio.
In operatioa~, then the connecting means 50 is
20 connected t~ the bag 20 and the barrier 8~ is closed
ar~aand the bag 20 as described above with reference to
FIB: ?, the receptacle 3.~~ is disposed generally
adjacent the bag 20 and is also necessarily enveloped
and enclosed bythe barrier 80.
A leak~tzght barrier or protection system is
established when the ~.op of the barrier 8~ is folded
t~~ether and x~lhd down a few turns and secured in
position by thevpli~ble tabs 92 as described above and
illustrated in ~'IOS. 2 anc'~ 3. With the leakstightness
,30 of the b~rriex system thus established, the'plug 3~ cai~
be removed fr~m the lower end of the neck 26 of the bag
2~ to permit the cbntents of the vial 22 to be
discharged into the bag 20 and be mixed therein.
When the barrier 80 is in the fully sealed
35 orientation as illustrated in FIG. 2, the discharge
WO 93»2002 PC'd'/1JS92/10918
- 20
valve 116 and the three-way valve 180 are, of course,
exposed for manipulation. The syringe x.20 can be
engaged with the distal end of the discharge valve 3.1.6,
and a desired amount of liquid can be withdrawn from the
bag 20 by operation of the syringe to establish suction
within the syringe.
If an air bubble is entrained with the liquid
flowing into the syringe, or if excess liquid is drawn
into the syringe, the air bubble and/or excess liquid
can be discharged into the receptacle 1~0. To this end,
the. syringe 120 is operated to discharge the desired ...
amount of the liquid back through the valve 11.6. The
check valve 102 in the first conduit 56 prevents back
flow into the bulk supply bag 20, but the check valve
2.5 150 permits flow from the syringe 120 toward the
receptacle 1~0: If the valve member 196 of the three-
way valve 180 is aligned as illustrated in FIG. 5, the
liquid discharged from the syringe 120 can pass into the
receptacle ~.~0 within:th~ barrier 180~ In this. manner,
a small amount of liquid containing an entrained air
bubble or a small amount of excess liquid can be
convenientl~r discharged to the receptacle 140 without
requiring removal of the syringe 120 fr~m the valve 11.6.
Thus, ;the receptacle 14O functions as a waste
receptacle within the barrier 80. Further, because the
receptacle 14~ a.s separate from the bulk supply bag 20,
aid ~ecab.se tire check val~re X02 does not permit flow
hack ~.nto °the bag 2 ~ ~ there is no danger .hat the bulk
supply in the bag 20 can bec~me contaminated with the
3~ ~~~id that had been previously withdrawn from the bag
~~,
If desired, the system may be operated in a
~~pumping" mode sa as to pump liquid from the bulk supply
bad ~0 to a separate container or remote location.
Specifically, the valve member 196 in the three-way
V~~ 93112002 PCT/US92/1091~
_ 21 _
valve 180 can be oriented to establish communication
between the second conduit 132 and the outlet port
conduit 192 while occluding the port conduit 191. The
outlet port conduit 192 can be connected directly to a
~5 separate fluid conduit system or to a separate
container, such as to a container of an intravenous
fluid. The syringe 120 can be operated to first
withdraw liquid from the bag 20 into the syringe, and
then the syringe can be operated to force the liquid
from the syringe through the conduit 132 and three-way
valve 180 to the other container or fluid conduit system
(not illustrated'.
The first connecting means 50 has been
illustrated as incorporating a hollow spike 52 for use
with a suitable reseal 46, and the second connecting
means 116 has been illustrated as a valve for use with a
suitable syringe 120. It will be appreciated, however,
that other systems xnay be provided for establishing a
connection with the bu7.k.supply bag 20 and for.effecting
a dispensing of the lic,~u~d from the end of the conduit
56. Thus, the (first connecting means 50, the conduit
5~, and'the second connecting means 116 (which could be
a dispensing valve as previously described), may be
characterized ~.og~ther in general terms as a first
.,
,i 25 conduit system ~r means for being connected to, and
extending frump the c~ntainer 20 to define a flow path
for the liquid from the coa~tainer to a discharge
location exterior of the container 20. Similarly, the
second conduit 132 may be. characterized as a second
conduit means for defining a flow path for the liquid
between a first end connected in fluid communication
with the first conduit means and a second end connected
..q
to the receptacle 140.
Further, it will be appreciated that although
~5 one aspect of the present invention relates to the use
w~ ~~i'zoox ~t:r~us~xrio~m
212 2 ~'~ ~. _ 22 -
of the novel barrier 80 with both a first conduit means
for withdrawing a liquid and a second conduit means
connected to a receptacle for accommodating excess or ,
waste liquid, the second conduit means 1.32 and connected
receptacle 140 may be omitted, or at least not used, in
those situations where there is no need to hold excess
liquid in a separate, sealed receptacle.
' Further, there may be applications involving
liquids which are not directly hazardous to personnel
1 0 but which may be potentially damaging to the environment
if not disposed of in an appropriate manner. In other ~.
applications, a liquid may not be directly hazardous and
may not even pose a potential danger to the environment,
but may be subject to strict inventory control. Thus,
another aspect of tlae present invention contemplates
that in either of these situations the system may be
provided without the barrier S0. 'Without the barrier
80, the system would still conveniently accommodate the
c~ll~:ction of the waste or excess liqu~.d in the.
receptacle 14~ so that the liquid in the receptacle ~.4~
would be readily susceptible to inventory control
prodessing and/or proper disgosal.
~. second embod~.ment of the present intention
is diagrammatically il.~.ustrated in ~TG. 6. This
2~ embodiment includes a barrier protection system in
combination with a la.q~id transfer system that-
incorporates deans for ransferr~.ng liquid to a syringe,
to an~ther fluid conducting system or container, and to
a waste receptacle.
3~ The second''embodiment includes a first
co~nectinc~ means, much as-a hollow spike 252. The spike
252 is adapted to penetrate a closure anembex~, such as a '
reseal (not illustrated), in a bulk supply bag or
contaia~~r 26~ (FIG. 7). Such a reseal and container may
351 Dae substantially the same as the reseal 46 and
t
eJV~ 9312002 PC'1'/LJS92/10~~8
- 23 -
21~~~~1 _
associated container 20 described above with reference
to the~first embodiment of the invention illustrated in
FIGS. 1--5. In FIG. 7, the reseal or other closure
contained on or in the container 260 has been omitted
for ease of illustration, and the hollow spike 252 is
shown penetrating the bottom of the container 260.
Prior to use, the hollow.spike 252 may be
covered with a suitable safety cap 253. The spike 252
is ~aounted on the end of a first conduit 256 which
penetrates a barrier 280. The barrier 280 is~flexible,
and may be fabricated from the same material as the ...
barrier 80 described above with reference to the first
embodiment illustrated in FIGS. 1-5. The barrier 280 is
sealed around the periphery of the first conduit 256 at
the location where the f'irst,conduit 256 penetrates the
barrier. The barrier 280 has a configuration that
permits its arrangement in an initial, retracted
orientation which pex~nits access to, and manipulation
~f, the cbnnecting means spike 252 and container 260.
Such an initial or~:enfiation is illustrated in FIG. 6.
The bag 280 accommodates subsequent
axrangement in an extended ~rientation (FIG. 7) for
,
around the first connecting means
defining an enclrssuxe
~~~ axed container 260. The top ~f 'the conta~.ner 260 may
~5 be adapted to be coupled to anotD~er container 262. The
container 262 nay be substantially identical to the vial
~:2 described- abdv~ with reference to the first
embodiment illustrated in FIGSa 1. and 2. Thus, the
contents from the container 262 can be emptied into, and
~ anixed wrath, a d~:luent or other lic~!id conta~.ned in the:
container 260. ~f c~urse, the assembly of the container
26~ coupled to the container 262 may not be the only
means for supplying liquid to the hollow spike 252.
ether contaia~ers c~uld be used, including a single
container of a pre-mixed, bulk supply of liquid.
vv~ 93i' zooz ~crru~~zm o9's
~~.2~~91
- - 24 - :...
In any event, the barrier 280 is adapted to be
sealed'at its open end by suitable means. FIG. 7
illustrates the use of,a interlocking, plastic rib
sipper-type seal 292 which may be of a suitable special
or conventional design, the details of which form no
part of the present invention.
The barrier 280 preferably has a wedge-shaped,
open-ended, envelope configuration which is
substantially reversible from the inside-out orientation
illustrated in FIG. 6 to the inverted orientation.
ill~.strated in FIG. 7. As schematically represented in.,.
FIG. 7, a first one-way, non-return valve or check valve
302 is mounted in the first conduit~or tube 256 to
prevent flow back into the bag 280. The check valve 302
,' Z5 may be a suitable special or conventional check valve
and may be identical to the check valve 102 described
above with .reference to the first eaabodiment of the
invention il3:ustra~ed in FIGS. 1-5.
1~ sec~nd connecta.ng means or dispensing ,valve
., '2~ 31.6, which includes a removable safety cap 326, is
mounted to the distal end of the first conduit 256. The
valve 3Z& may be a suitable special or conventional
valve- adapted for use with a syringe (not illustrated
and may be ident~.cal to' the valve employed as the second
2~ cor9necting means 116 described above with reference to
the eodiment illustrated in FIGS. 1-5.
'~ A second conduit means or tube 332 extends
from the first conduit 256 td a receptacle 340. The .
.a
receptacle 340 includes a sheet of flexible,
3~ theranoplast~.c material sealed about its periphery to the
outs~.de sur~~ce of the barrier 280. The receptacle 340
functions in the same manner as the receptacle 140 in
the first embodiment described above'with deference to
'; FIGS. 1-5, and the receptacle 340 receives excess or
35 waste liquid and/or entrained air.
vv~o g3i' zooz Pc-rms~zi' 09~ ~
_ ' 25 ' ~~~u~~
A onewway, non~return valve or check valve 350
is provided in the second conduit 332 as schematically
illustrated in FIG. ?. The check valve 350 prevents
flow out of the receptacle 340. The check valve 350 may
be a suitable special or conventional valve and may be
identical to the check valve 150 described above with
reference to the first embodiment of the invention
illustrated in FIGS. 1~5.
A third conduit 410 is connected at one end in
l0 fluid communication with the second conduit 332 between
the first conduit 256 and the second check valve 350. w
The third conduit 4~.0 terminates in a second end having
a suitable dispensing structure or fitment 415 from
which liquid may be discharged. The fitment 425, as
schematically illustrated in FTG. 7, may be a
conventional connection of the kind sold under the
designation LIFE~SHI~Lmg°~ Co~nec~or ~.n the U.S.A. by
Abbott Taaboratories having an office at PTorth Chicago,
Illinoa.s. Such, a fitment 415 includes a hollow spike
4~.? surrounded by a cylindrical shield 41~. The fitment
415 is adapted to be connected to a suitable receiving
port in an intraveno~x~ bag system (not illustrated).
The detailed design and structure of the fitment 415
form no part of the present invention.
In order tc-prevent flow from the third
conduit 410 back'into the second conduit 332, a third
one-way, n~n-ret~arra valve or check valve 426 i.s provided
~.n the third conduit ~1~. The check valve 426 may be
identical to the check valv,~e 350 described above.
In the 'embodiment illustrated ix~ FTG. ?, there
is ~o three--way valve, such as the three-way valve 180
illustrated in FTG. 5 for the previ~usly described first
embodiment. Rather, a conventional slide clamp 430 is
provided on the second conduit 332, and a second slide
clamp 434 is provided on the third conduit 410. The
V1VC193/ 12002 ~'~C1'liJ~921 ~ 091 ~
~~.2~~91 _ zs -
slide clamps 430 and 434 may have a suitable special or
conventional design. A suitable conventional clamp is
made under the designation list No. ~5--~1S7 Slide Clamp
by Abbott Laboratories having an office at North
Chicago, Illinois. Each slide clamp functions as an .
isolation valve means for selectively closing or opening
the conduit on which it is mounted:
' The two slide clamps 430 and 434 can be
employed to selectively direct the flow to either the
1~ .receptacle 340 or the fitment 415. In particular, if it
is desired to discharge excess or waste liquid,
including liquid with entrained air, 'to the receptacle
340, then the slide clamp 434 is adjusted to close off
the conduit 4~.0, and the clamp 430 is maintained in an
open position on the second conduit 33z. Alternatively,
if it is desired to transfer liquid to the third conduit
41~, the slide clamp 434 is adjusted to the open
position, and then the slide clamp 430 is adjusted to
the closed position so as to pinch the second conduit
2~ 33z closed.
~lith the system illustrated in ~'IG, ~, a
syringe, such as the syringe 120 described above with
reference to the first embodiment illustrated in FIGS.
~.-5,'may be employed for withdrawing liquid from the
c~ntain~r 260. Further, lic~u~.d can be °°pumped°°
from the
container 26~ through the third conduit 41~ by operation
of the syringe in the same manner as described above
with reference ~o the first embodiment.
The barrier system of the invention
functions to prpt~ct~personnel from a hazardous liquid
leak, and the barrier system can be relatively easily
and quickly manipulated as necessary to provide the
barrier protection around a variety of containers having
various shapes and sizes.
' _,; , , :. ;; , ;. .. . . . .,' .. ~ : - .. ._,: v , ,~- ~., ~.. , ,., y:
dVC9 93/32002 fGT/US92/1~9'6~
- 27 - ~~.~~~~~.
Further, regardless of whether or not the
barrier protection system is needed or employed, an
additional feature of the invention provides a novel
liquid transfer system for accommodating withdrawal of
liquid from a container with a syringe. The system
permits the syringe to be used as a pump to discharge
precise amounts of the liquid directly to another fluid
conduit system or to an intravenous container-~--all
without apening the system to ambient atmosphere.
It will be readily apparent from the foregoing
detailed description of the invention and from the
illustrations thereof that numerous variations and
modifications may be effected without departing from the
true spirit and scope of the novel concepts or
principles of this invention.
